Michael Köhler

Contributions

Why clinical study reports really matter - Volume 27, Issue 2

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available…

Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies - Volume 22, Issue 3

For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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